6
Important Information
WARNINGS
WARNING! Risk of explosion, fire, or
serious injury
If you use the Accuro in the presence
of flammable anesthetics, the hazard
of potential explosion exists.
Do not place the Accuro near a heat
source or expose it to direct flame.
Such exposure may lead to corrosive
liquid leakage, electrical shock, or fire.
Stop using the Accuro if the casing is
damaged. Failure to do so may result
in electrical shock or fire.
Electrical shock may result from
using damaged USB cables with the
Accuro or if modifications are made
to the Accuro by anyone other than
personnel authorized by RIVANNA.
Only use RIVANNA approved cables
with the Accuro.
Avoid dropping or subjecting the
Accuro to severe impacts. This could
result in electrical shock, corrosive
liquid leakage, and injury.
If battery leakage is present, wear
protective gloves and discard the
Accuro immediately following
applicable regulations.
WARNING! Potential patient hazard
Do not use the Accuro instrument for
ophthalmic indications.Ophthalmic use
may cause patient injury.
CAUTIONS
CAUTION: Potential patient hazard
from acoustic exposure
To date, exposure to diagnostic
medical ultrasound has not
been shown to produce adverse
health effects. However, medical
professionals should use ultrasound
only when clinically indicated.
Medical professionals should use the
lowest exposure times possible. The
ultrasound output of the Accuro is not
user-adjustable and is limited to the
minimum level necessary for effective
performance.
CAUTION: Hazardous materials
present. Assure proper disposal.
The Accuro may contain mineral oils,
batteries, and other environmentally
hazardous materials. When the Accuro
has reached the end of its useful
service, follow your local protocols for
hazardous waste disposal.
CAUTION: Assure proper distance
from patient
When transmitting data to or from
your computer, make sure that the
Accuro, accessories, and the computer
are outside of the patient vicinity
(more than six feet from the patient).
CAUTION: Assure proper computer
system and/or printer configuration
When using the Accuro with an
external computer system and/or
printer unit, the computer system
and/or printer unit or a charger, the
computer system and/or printer unit
or charger must be minimally certified
to EN/IEC 60601-1 system standard.
CAUTION: Damage to the
instrument may occur
Only apply commercially available
ultrasonic couplant, which has been
specifically formulated for use in
medical applications, to the acoustic
window (or face) of the probe. Failure
to do so may cause damage to the
Accuro instrument.
CAUTION: Damage to the
instrument may occur
Do not attempt to sterilize the Accuro
instrument. Damage to the Accuro
instrument may occur.
CAUTION: Damage to the
instrument may occur
Hot water in excess of 113°F or 45°C
may damage the instrument.
CAUTION: Damage to the
instrument may occur
Do not immerse the instrument in
disinfectant solution.
CAUTION: Images and calculations
are not to be used as the sole basis
for clinical diagnosis
The images and calculations provided
by the Accuro instrument are intended
for use by competent users, as a
diagnostic tool. They are explicitly
not to be used as the sole, irrefutable
basis for clinical diagnosis. Users are
encouraged to account for the clinical
utility of the Accuro and make their
own professional conclusions.
CAUTION: Risk of inaccurate
measurements
The images and calculations provided
by the Accuro instrument are intended
for use by competent users, as a
diagnostic tool. The user should be
aware of the instrument specifications,
accuracy, and limitations. These
limitations must be considered before
making any decision based on images
and quantitative values.
Incorrect image settings, equipment
malfunction, or failure to correctly
operate the Accuro can result in
measurement errors or failure to
detect certain details in the image.
The user must be thoroughly familiar
with the operation of the Accuro in
order to optimize its performance and
to recognize possible malfunctions
and limitations. Application training
is available through the sales
representative.
CAUTION: Ensure security of
protected health information
Protected health Information (PHI)
such as personal identifiers can
be manually entered on Accuro
to associate with image data. To
best secure PHI during storage and
transfer, it is recommended to always
use password protection and maintain
anonymous image files. Both can be
configured from the SETTINGS screen.
If Accuro needs to be transported for
repair, ensure that all patient data is
backed up and confirm that backup
was successful. All patient data must
be erased from internal memory of
Accuro before shipment.